Regulation (EC) No 1223/2009 aims to comprehensively harmonize cosmetic product rules in the EU to ensure consumer safety and an internal market. It replaces the previous Cosmetic Directive with stricter rules, including requiring responsible persons to submit product information to the Commission and keep files. The regulation strengthens provisions around nanomaterials and monitoring of products in the market. It will enter into force on July 11, 2013 to apply a single set of cosmetic safety rules throughout the EU.

1. REGULATION (EC) No 1223/2009
OF THE EUROPEAN PARLIAMENT
AND OF THE COUNCIL
on cosmetic products

2. BACKGROUND
Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating
to cosmetic products has been significantly amended on several occasions.
Since further amendments are to be made, in this particular case it should be recast as one single text in the
interests of clarity.
A Regulation is the appropriate legal instrument as it imposes clear and detailed rules which do not give room
for diverging transposition by Member States. Moreover, a Regulation ensures that legal requirements are
implemented at the same time throughout the Community.
This Regulation aims at simplifying procedures and streamlining terminology, thereby reducing administrative
burden and ambiguities. Moreover, it strengthens certain elements of the regulatory framework for cosmetics,
such as in-market control, with a view to ensuring a high level of protection of human health.
This Regulation comprehensively harmonises the rules in the Community in order to achieve an internal
market for cosmetic products while ensuring a high level of protection of human health.
The regulation was signed on 30 November 2009 and it will be completely replaced the current valid EC
Cosmetic Directive 76/768 and by extension most of the national provisions which are set out in the differents
EU member states.
Regulation 1223/2009 will enter into force on 11 July 2013

3. DEFINITIONS
Cosmetic Product means any substance or mixture intended to be placed in contact with the external parts of
the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the
mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them,
changing their appearance, protecting them, keeping them in good condition or correcting body odours
Manufacturer means any natural or legal person who manufactures a cosmetic product or has such a product
designed or manufactured, and markets that cosmetic product under his name or trademark
Distributor means any natural or legal person in the supply chain, other than the manufacturer or the
importer, who makes a cosmetic product available on the Community market
Making available on the market means any supply of a cosmetic product for distribution, consumption or use
on the Community market in the course of a commercial activity, whether in return for payment or free of
charge
Placing on the market means the first making available of a cosmetic product on the Community market
Responsible person Only cosmetic products for which a legal or natural persons designated within the
Community as ‘responsible person’ shall be placed on the market.
For each cosmetic product placed on the market, the responsible person shall ensure compliance with the
relevant obligations set out in this Regulation.
The distributor shall be the responsible person where he places a cosmetic product on the market under his
name or trademark or modifies a product already placed on the market in such a way that compliance with
the applicable requirements may be affected.

4. NEW FOCUS ON SAFETY
The safety requirements to be metby products have been reformulated in Article 3 of Chapter II.
It stipulates that cosmetic prodcuts must be safe when applied under normal or reasonably conditions
of use.
The requirement that a product must be safe is worded more strictly than in the previous provision
which states that a cosmetic product may not cause damage to health.
NB data referred to US market only
With more than 11 billion personal care products sold each year, and typically only 150 adverse
experiences (mostly skin rashes or allergies) reported, cosmetics remain the safest category of products
regulated by the FDA (drugs, medical devices, food, cosmetics and tobacco).

5. EYE ON QUALITY: COSMETIC cGMP
The manufacture of cosmetic products shall comply with good manufacturing practice with a view to
ensuring the objectives of Article 1
Compliance with good manufacturing practice shall be presumed where the manufacture is in accordance
with the relevant harmonised standards, the references of which have been published in the Official Journal
of the European Union (i.e. ISO 22716:2007 Cosmetics -- Good Manufacturing Practices (GMP) -- Guidelines
on Good Manufacturing Practices).
ISO 22716:2007 gives guidelines for the production, control, storage and shipment of cosmetic products.
These guidelines cover the quality aspects of the product, but as a whole do not cover safety aspects for the
personnel engaged in the plant, nor do they cover aspects of protection of the environment.
The guidelines in ISO 22716:2007 are not applicable to research and development activities and distribution
of finished products

6. PRODUCT INFORMATION FILE
When a cosmetic product is placed on the market, the responsible person shall keep a product information
file for it.
The product information file shall be kept for a period of ten years following the date on which the last batch
of the cosmetic product was placed on the market.
The responsible person shall make the product information file readily accessible in electronic or other
format at his address indicated on the label to the competent authority of the Member State in which the file
is kept.
The information contained in the product information file shall be available in a language which can be easily
understood by the competent authorities of the Member State.
The requirements provided in paragraphs 1 to 3 of this Article shall also apply to cosmetic products that
have been notified under Directive 76/768/EEC.

7. PRODUCT INFORMATION FILE
The product information file shall contain the following information and data :

8. PRODUCT INFORMATION FILE
According to Article 40 of the Regulation, the P.I.F. requirement (Article 11) will apply on 11 July 2013.
However, according to article 39, by way of derogation from the Directive, cosmetic products placed on the
market before 11 July 2013 may already comply with the P.I.F.-related requirements of the Regulation.
In this case, such products need not also comply with Article 7a of the Cosmetics Directive.
As a consequence, companies can choose whether to update the P.I.F. before 11 July 2013.
Even if the cosmetic product was notified under the new Regulation between 11 January 2012 and 10 July
2013, the PIF does not have to be compliant with article 11 before 11 July 2013.
In any case, for cosmetic products placed on the market from 11 July 2013, the PIF must comply with
requirements of Article 11.

9. PRODUCT INFORMATION FILE
In summary, on 11 July 2013, the following cases must be considered:

10. PRODUCT NOTIFICATION
Prior to placing the cosmetic product on the market the responsible person shall submit, by electronic
means, the following information to the Commission:
(a)the category of cosmetic product and its name or names, enabling its specific identification;
(b) the name and address of the responsible person where the product information file is made readily
accessible;
(c) the country of origin in the case of import;
(d) the Member State in which the cosmetic product is to be placed on the market;
(e) the contact details of a physical person to contact in the case of necessity;
f) the presence of substances in the form of nanomaterials and:
(i) their identification including the chemical name (IUPAC)and other descriptors as specified in point 2 of
(ii) the Preamble to Annexes II to VI to this Regulation;
(ii) the reasonably foreseeable exposure conditions;
(g) the name and the Chemicals Abstracts Service (CAS) or EC number of substances classified as
carcinogenic, mutagenic or toxic for reproduction (CMR), of category 1A or 1B, under Part 3 of Annex VI to
Regulation (EC) No 1272/2008;
(h) the frame formulation allowing for prompt and appropriate medical treatment in the event of difficulties.

11. NANOMATERIALS
Nanomaterial means an insoluble or bio-persistant and intentionally manufactured material with one or
more external dimensions, or an internal structure, on the scale from 1 to 100 nm.
According to the Regulation, a long list of information regarding nano materials shall be send to the
Commission in order to give all the assurances from a toxicological point of view.
In the event that the Commission has concerns regarding the safety of a nanomaterial, the Commission
shall, without delay, request the SCCS to give its opinion on the safety of such nanomaterial for use in the
relevant categories of cosmetic products and on the reasonably foreseeable exposure conditions.
The Commission shall make this information public. The SCCS shall deliver its opinion within six months of
the Commission’s request.
Where the SCCS finds that any necessary data is lacking, the Commission shall request the responsible
person to provide such data within an explicitly stated reasonable time, which shall not be extended.
The SCCS shall deliver its final opinion within six months of submission of additional data. The opinion of the
SCCS shall be made publicly available.
LABELLING OF NANOMATERIALS
All ingredients present in the form of nanomaterials shall be clearly indicated in the list of ingredients. The
names of such ingredients shall be followed by the word ‘nano’ in brackets.

12. COSMETOVIGILANCE
Member States shall monitor compliance with this Regulation via in-market controls of the cosmetic products
made available on the market.
They shall perform appropriate checks of cosmetic products and checks on the economic operators on an
adequate scale, through the product information file and, where appropriate, physical and laboratory checks
on the basis of adequate samples.
Member States shall also monitor compliance with the principles of good manufacturing practices.
In the event of serious undesirable effects, the responsible person and distributors shall without delay notify
this to the competent authority of the Member State where the serious undesirable effect occurred
Where the responsible person reports serious undesirable effects to the competent authority of the Member
State where the effect occurred, that competent authority shall immediately transmit the information
referred to in paragraph 1 to the competent authorities of the other Member States.
Where distributors report serious undesirable effects to the competent authority of the Member State where
the effect occurred, that competent authority shall immediately transmit the information referred to in
paragraph 1 to the competent authorities of the other Member States and to the responsible person.
Where end users or health professionals report serious undesirable effects to the competent authority of the
Member State where the effect occurred, that competent authority shall immediately transmit the
information on the cosmetic product concerned to the competent authorities of the other Member States and
to the responsible person.

13. 1223/2009 COMPLIANCE CHART